Pandemic Flu - Public Health Research Guide

Table of Contents

This guide focuses on the law related to efforts in preventing, detecting and containing human influenza on the international, regional and national level.

INTRODUCTION

The spread of human influenza does not respect national boundaries and there could be simultaneous outbreaks in different parts of the world. Co-ordination of preparedness and response at the international, regional, and national level is therefore essential.

This research guide focuses on the law related to the efforts in preventing, detecting and containing human influenza on the international, regional and national level (focusing on the United States).

For resources on the broader topic of health law and bioethics, please consult:

Avian Influenza (World Organisation for Animal Health, OIE)
Web site maintained by the World Organisation for Animal Health to help governments and the veterinary services of member countries which are affected by or which want to protect the territories from the disease.

EISS Weekly Electronic Bulletin (European Influenza Surveillance Scheme, EISS)
Published every Friday during the influenza season, EISS Weekly Electronic Bulletin provides the general public and concerned parties with information on influenza activity in Europe. It also publishes commentary written by experts from the EISS group.

SOURCES OF LEGAL AUTHORITY

International / Regional

The World Health Organization

The World Health Organization is charged with the coordination and monitoring of disease outbreaks across the globe. Specifically, under the revised International Health Regulations, IHR (2005) (entered into force in June, 2007), deals with the public health response framework public health emergencies.

United States - Federal

Like police powers, most public health authority is based in the states (10th Amendment to the Constitution). However, federal public health recommendations significantly influence state public health practice. Besides, the federal government has authority to control entries of persons, goods and conveyances from other countries and impose quarantine. Moreover, emergency responses needed in Louisiana and Mississippi because of the devastating hurricane Katrina in 2005 have sparked debates over the role of the military in responding to disasters.

Below is a selected list of statutes that give the federal government authority to deal with large scale emergencies:

National Emergencies Act (50 U.S.C. § 1601 et seq.) provides the President with the power to declare an emergency.

Homeland Security Act (6 U.S.C. § 101 et seq.) creates the Department of Homeland Security and grants the Secretary of Homeland Security a broad leadership role in planning for and responding to emergencies.

Public Health Service Act (PHSA) (42 U.S.C. § 201 et seq.) "creates important vehicles for federal funding of public health activities in state and communities."

Section 319 of the Public Health Service Act (42 U.S.C. § 247d) authorizes the HHS Secretary to declare a public health emergency and "take such action as may be appropriate to respond" to that emergency consistent with existing authorities.

Section 361 of the Public Health Service Act (42 U.S.C. §264) gives the Secretary of Health and Human Services responsibility for preventing the introduction, transmission, and spread of communicable diseases from foreign countries into the US and within the US and its territories/possessions. The statute is implemented through regulations found at 42 C.F.R. Parts 70 and 71. Under its delegated authority, the Centers for Disease Control and Prevention (CDC) is empowered to detain, medically examine, or conditionally release individuals reasonably believed to be carrying a communicable disease. As of October 31, 2007, the CDC maintains 20 quarantine stations in the U.S.

Federal Food, Drug and Cosmetics Act (FFDCA) (21 U.S.C. § 301 et seq.) "authorizes the FDA to regulate the safety of food and cosmetics, and the safety and effectiveness of pharmaceuticals, biologics, and medical devices." The HHS Secretary can authorize emergency use of unapproved products or approved products for unapproved uses under section 564 of FFDCA (21 U.S.C. §360bbb-3).

Appendix E: Legal Authorities to the HHS Pandemic Influenza Plan outlines key pandemic response issues (such as public sector vaccine or antiviral drug purchase, indemnification of manufacturers, compensation for persons injured by vaccine or antiviral medications, etc.) and legal authorities. For statutes not listed above or in Appendix E to the Plan, check the United States Codes (Title 21 - Food and Drugs, Title 24 - Hospitals and Asylums, and/or Title 42 - Public Health) available at:

Newsletters, such as BNA publications, and other current awareness tools (discussed later in this research guide) are also good sources of proposed federal legislation.

United States - States

Many state public health statutes were enacted in response to specific diseases or health threats. In 2000, the Turning Point Public Health Statutes Modernization Collaborative was formed to address the need to reform state statutes to improve the public health system. The Collaborative created and presented in September 2003 the Model State Public Health Act which is designed to serve as a tool for state, local, and tribal governments to use to revise or update public health statutes and administrative regulations. Other model state acts that relate to public health are:

State Quarantine and Isolation Laws
Summary of state laws (does not include District of Columbia, or other territories) regarding quarantine and isolation. Created by the Health Policy Tracking Service (HPTS) at iNETSCAN Publishing (now part of Thomson) for Trust for America's Health (TFAH). The review was conducted from July to November 2004.

District of Columbia - D.C. Code Ann. §7-131 et seq. The Mayor may, upon the advice of the Commissioner of Public Health, issue rules to prevent and control the spread of communicable diseases...; D.C. Mun. Regs. tit. 22 §200 et seq.

Virginia - VA. Code Ann. §32.1-43 et seq. The State Health Commissioner shall have the authority to require quarantine, isolation, immunization, decontamination, or treatment of any individual or group of individuals when he determines any such measure to be necessary; 12 VA. Admin. Code § 5-90-105, 5-90-110.Summary of state laws (does not include District of Columbia, or other territories) regarding quarantine and isolation.

EMERGENCY PREPAREDNESS & RESPONSE PLANS

Federal and state statutes give appropriate agencies and officials the legal authority to carry out their responsibilities in an emergency situation The following are emergency preparedness and response plans devised by health agencies of international/regional organizations and U.S. Federal and state governments. These plans provide the blueprints for preparing for and responding to a pandemic outbreak.

International / Regional Organizations

WHO Global Influenza Preparedness Plan: The Role of WHO and Recommendations for National Measures Before and During Pandemics (WHO /CDS/CSR/GIP/2005.5) (WHO Department of Communicable Disease Surveillance and Response, Global Influenza Programme)
The WHO global influenza preparedness plan has been prepared by staff from the WHO Secretariat after a 3-day consultation meeting in December 2004 in Geneva attended by representatives from national influenza centers from around the word. The plan was prepared to assist WHO Member States and those responsible for public health, medical and emergency preparedness to respond to threats and occurrences of pandemic influenza. It recommends actions for national authorities, and outlines measures to be taken by WHO during each phase of a pandemic. There are six WHO influenza pandemic phases (see page 11 of the report): Phase 0 (inter-pandemic phase) to Phase 5 (confirmation that the pandemic has ended).

Global Strategy for the Progressive Control of Highly Pathogenic Avian Influenza (Food and Agriculture Organization (FAO, Rome), World Organization for Animal Health (OIE, Paris) in Collaboration with World Health Organization (WHO, Geneva) May 2005)
A draft master coordination plan with a global vision defining the road map and time frames for the short, medium and long term priority activities, produced in response to the recommendation made during the 2nd FAO/OIE Regional Meeting on Avian Influenza Control in Asia (23-25 February, 2005) held in Ho Chi Minh City, Viet Nam. The strategy paper will be consolidated and complemented by more detailed country specific avian influenza control plans prepared for several countries in Southeast Asia.

AGENCIES RESPONSIBLE FOR EMERGENCY PREPAREDNESS & RESPONSES

International

World Health Organization's (WHO) Epidemic and Pandemic Alert and Response (EPR) [http://www.who.int/csr/en/]
The overall framework for EPR's strategy is the International Health Regulations (IHR) (for more information about IHR, check "Sources of Legal Authority" below). EPR focuses on the leading epidemic and emerging diseases. It develops and strengthens specific global surveillance and response networks for diseases such as influenza, meningococcal meningitis, plague, SARS, viral haemorrhagic fevers (Ebola, Lassa) and yellow fever. EPR's epidemic intelligence system gathers and verifies outbreak information daily from around the world and coordinates international responses to outbreaks of global importance, under its operational arm, the Global Outbreak Alert and Response Network. EPR also supports the strengthening of national capacity for alert and response.

Regional

Europe

European Influenza Surveillance Network (EISS)
Funded by the Health and Consumer Protection Directorate-General, European Commission EISS collects and exchanges timely information on influenza activity; contributes to the annual determination of the influenza vaccine content, providing relevant information about influenza to health professionals and the general public and the general public and contributes to European influenza pandemic preparedness.

Latin America

United States - Federal

Many federal agencies are responsible for various aspects of emergency preparedness and response. The HHS Pandemic Influenza Plan (November 2005) prepared by the Department of Health and Human Services provides a summary of major pandemic preparedness roles of HHS officials, agencies and divisons (Table 3). The section on HHS Actions for Pandemic Influenza Preparedness and Response summarizes key actions and responsible agencies by pandemic phase. Roles played by other federal departments are not detailed in the plan, nor are the coordination and communication amongst departments and agencies. A brief description of the roles played by HHS officials, agencies and divisions is as follows. For a more detailed list, please refer to Table 3 of the HHS Pandemic Influenza Plan (November 2005):

National Vaccine Program Office (NVPO)
Coordinates development and revisions of the pandemic preparedness and response plan; coordinates and monitors preparedness activities during the inter-pandemic period, reporting to ASH; coordinates HHS agencies on vaccine issues via the Interagency Vaccine Group (IAVG).

Centers for Disease Control and Prevention (CDC)
Works with partners throughout the nation and the world to monitor health, detect and investigate health problems; develops, evaluates and modifies disease control and prevention strategies; stockpiles antiviral drugs and other essential materials; promotes and supports influenza vaccination programs. The Influenza Pandemic Operation Plan (OPLAN) is published by the CDC.

National Vaccine Advisory Committee (NVAC)
The NVAC is made up of 15 members appointed for rotating four-year terms by the Director of the NVP in consultation with the National Academy of Sciences, from among individuals who are engaged in vaccine research or the manufacture of vaccines; or who are physicians, members of parent organizations concerned with immunizations, or representatives of state or local health agencies or public health organizations. The Committee advises the Assistant Secretary for Health (ASH) on pandemic preparedness from perspectives of the multiple stakeholders including in the committee membership.

Vaccines and Related Biological Products Advisory Committee (VRBPAC)
Advises the Commissioner of Food and Drugs in discharging his responsibilities as they relate to helping to ensure safe and effective biological products, and as required, any other product for which the FDA has regulatory responsibility.

Department of Homeland Security (DHS)
Has the overall authority for emergency response activities and will coordinate interventions to maintain community services during a pandemic.

United States - State

It is particularly important for California to have a strong influenza surveillance program as it has several ports of entry for flights and shipping from Asia. The California Influenza Surveillance Project (CISP) obtains and analyzes hospital, pharmacy and laboratory data year-round in an effort to determine the timing and impact of influenza activity and to determine how well circulating strains of the virus match those used in the current influenza vaccines. The Web site provides weekly surveillance updates during the flu season.

Journal Articles

Medical Journal Articles

Medline
This is the most important index for U.S. medical journals, and includes many international ones as well. Medline (Ovid), see below, is the best way for Georgetown students and faculty to use Medline, because the full text of some articles are available. Medline is also available for free on the Web (without full text) through the PubMed service at the National Library of Medicine. It is also available as a database on Lexis (Legal > Area of Law - By Topic > Medical > Medical Reference > Medline References) and Westlaw: MEDLINE (without full text of articles).

Medline (Ovid) (1951- ) A version of Medline with access to the full text of many articles. Available to Georgetown faculty and students only through the Medical Center's Dahlgren Library. (Georgetown Law on-campus access only)

Public Health Journals

Below is an alphabetical list of leading public health journals and periodicals with a focus on infectious diseases.

Eurosurveillance
A joint project since 1995 of the Institut de veille sanitaire at Saint-Maurice, France, and the Health Protection Agency Centre for Infections in London, United Kingdom, funded by the European Commission's Directorate-General for Health and Consumer Protection (DG SANCO), Eurosurveillance is a free journal with monthly and weekly releases publishing "authoritative, peer-reviewed information on communicable diseases from a European perspective." Target readers are professionals and policy makers in the field of communicable diseases.

Weekly Epidemiological Record (World Health Organization)
"[A]n essential instrument for the collation and dissemination of epidemiological data useful in disease surveillance on a global level. Priority is given to diseases or risk factors known to threaten international health."

2. Indexes/Databases

PolicyFile (1990-) (Georgetown Law only)
Indexes and abstracts public policy research and analyses originating from think tanks, university research programs, research organizations, and publishers (includes GAO Reports, but not CRS Reports). Where available, access to home pages and full text are made available within individual abstracts.

PAIS International (1972-) (Georgetown Law On-campus access only)
Indexes public policy and public affairs literature.

CQ Researcher Weekly publication covers the most current and controversial issues of the day with complete summaries, insight into all sides of the issues, bibliographies and more. It published a report on the Avian Flu Threat on January 13, 2006.

Congressional Research Service Reports (CRS Reports)
These are non-partisan and in-depth reports produced by the Congressional Research Service, the research arm of the Library of Congress, on a variety of topics for Congress. They are not widely available, but a few libraries have been collecting and making them accessible:

Open CRS: Congressional Research Reports for the People
A project of the Center for Democracy & Technology that serves as a centralized location to learn about the Congressional Research Service and search for CRS reports that have been released to the public by members of Congress. Provides report summaries.

Other International Organization Web Sites

The Global Economic and Financial Impact of an Avian Flu Pandemic and the role of the IMF (Prepared by the Avian Flu Working Group of the International Monetary Fund in consultation with Departments and the Joint Bank-Fund Health Services Department), February 28, 2006. This document "discusses the Fund's role in helping members prepare their economic and financial systems for the possibility of an avaian flu pandemic." The document will be updated on a periodic basis.

Other U.S. Government Web Sites

EPI-X: The Epidemic Information Exchange (CDC)
"The Center for Disease Control and Prevention's secure, web-based communications network that serves as a powerful communications exchange between CDC, state and local health departments, poison control centers, and other public health professionals. The system provides rapid reporting immediate notification, editorial support, and coordination of health investigations for public health professionals." This Web site provides the public with information about this secure network.

Public Health Emergency Response Guide for State, Local, and Tribal Public Health Directors (CDC)
"[A]n all-hazards reference tool for health professionals who are responsible for initiating the public health response during the first 24 hours (i.e. the acute phase) of an emergency or disaster. It provides useful information on the activation and integration of a jurisdiction's public health system into the existing overall emergency response structure during the acute phase of an incident."

Strategic National Stockpile (CDC) is a national repository of pharmaceuticals and medical material to supplement and re-supply state and local public health agencies in the event of a national emergency. The Web site provides general information such as what Strategic National Stockpile is, how and when it is deployed. The Web site also includes some training material for state and local health care providers, first responders, and governments.